Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
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| ClinicalTrials.gov Identifier: NCT01491178 |
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Recruitment Status :
Completed
First Posted : December 13, 2011
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Atrial Fibrillation | Drug: Prazaxa |
| Study Type : | Observational |
| Actual Enrollment : | 6772 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation |
| Actual Study Start Date : | December 12, 2011 |
| Actual Primary Completion Date : | August 2, 2016 |
| Actual Study Completion Date : | August 2, 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Patients with NVAF |
Drug: Prazaxa
Dabigatran etexilate |
- Frequency (Percentage) of Participants With Adverse Drug Reactions [ Time Frame: Up to 104 weeks from first administration of study drug ]Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".
- Incidences of Stroke and Systemic Embolism (SEE) [ Time Frame: Up to 104 weeks from first administration of study drug ]Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.
Exclusion criteria:
- None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491178
Show 1164 Study Locations
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01491178 History of Changes |
| Other Study ID Numbers: |
1160.130 |
| First Posted: | December 13, 2011 Key Record Dates |
| Results First Posted: | January 30, 2018 |
| Last Update Posted: | January 30, 2018 |
| Last Verified: | July 2017 |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |